# K926385: Bard Apii Pump

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Apr 18, 1994 after 482 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K993387: Ipump Pain Management System, Model 2L3107K (1999), 3 descendants of its own
- K052973: Ipump Pain Management System, Model 2L3107, 2L3107K (2007), 2 descendants of its own
- K120209: Patient Controlled Analgesia (Pca) Button Cable (2012), 1 descendant of its own
- K220695: Elite Biomedical Solutions Dose Request Cord (2022), 0 descendants of its own

## Recalls of this device
- Dec 21, 2005 · Not classified · Z-0552-06: Delivery of unrequested PCA doses of medication due to damaged PCA cords, partial sticking of PCA button, and fluid ingress into the pump or PCA button.
- Oct 27, 2005 · Not classified · Z-0550-06: When infusing at flow rates below 0.5 mL/hr, the upstream occlusion alarm of the pumps may not detect the occlusion.

Source page: https://510kreport.com/device/K926385
Methodology: https://510kreport.com/methodology